i'm new to this board but write frequently on nfld board at yahoo.
I've been following nfld for 3 years and have spoken with gould and dewoskin, the guys in charge, at the annual meeting the past two years. I believe nfld is the leader in this field and will be fda approved by sept 99. They have made significant progress in transfusion therapy as evidenced by their 10 unit transfusions in trauma patients (the equivalent of replacing the entire blood volume of a 70 kg individual)(phase 2 studies, still accumulating patients) I believe they will form some significant partnerships in the next few weeks that will allow them to avoid building their own manufacturing facility.
Biopure has an interesting product but we will have to see if the side effect profile in humans is similar to what it is in dogs. this stuff cannot be infused at a rapid rate without serious side effects (pulmonary edema). therefore, if the same is true in humans, (unknown), it will not be useful in a surgical setting where infusions must occur rapidly if not instantaneously in severe trauma. Biopure will need to demonstrate safety to fda first, then safety at large volumes in order to have a viable product. If, by some weird quirk it does work, then nfld's polyheme is a dead product. Remember, phase 3 in europe is nothing by way of comparison to phase 3 of our fda. do not try to utilize european studies by biopure to suggest that this is going to be a viable product. Rather, the real clue will come from fda phase 2 study performed in this country. A one or two unit study is worthless, if you need just one or two units of blood, you might as well just get a routine transfusion or nothing at all. All i want to say about this company is be cautious in any interpretation of data. they are still years away from completing the necessary studies while nfld is likely to finish phase 3 in the next 3-4 months. Just my opinion. |
